At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
Summary: Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations.
Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Major Duties and Responsibilities
- ✓Quality floor support for minor and routine manufacturing activities
- ✓Performs routine manufacturing batch production record review for media/buffer/cryo in support of product release in accordance with specifications and SOPs.
- ✓Perform walkthroughs of GMP areas documenting observations and areas of concern.
- ✓Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
- ✓Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
- ✓May support the Quality review of manufacturing deviations.
- ✓May support release of incoming or manufactured products
- ✓Routine QA Floor Support Activities, including but not limited to alarm review, logbook review, etc.
- ✓Other duties as assigned
Knowledge and Skill
- ✓Knowledge of biotech bulk and finished product manufacturing, analytical testing is desirable.
- ✓Familiarity with US and EU cGMP regulations and guidance.
- ✓Working knowledge of common computer systems such as MS-Word and Excel is required.
- ✓Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking, and maintenance is desirable.
Qualifications
- ✓A B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
- ✓A combination of 2 years relevant experience in a regulated environment or mix of Co-Op and regulated environment is preferred
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Devens - MA - US: $81,800 - $99,117